The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children

Anxiety Clinical Trial

Official title:

The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881941
• Other study ID #: EskisehirOU2643
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 8, 2022

Study information

• Verified date: May 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.

Description:

This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 8, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• the child should be between the ages of 3-6,

• will receive inhaler treatment,

• the mother or father should be with the child during the procedure,

• not have used any sedative drugs in the last 8 hours before the application,

• written consent has been obtained from the parents after the procedure,

• the child is not crying before the start

Exclusion Criteria:

• the child is younger than 3 years old, older than 6 years oldu,

• the childe has a mental disability,

• communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),

• the child has pain,

• the child is the terminal period,

• the parent has a situation that prevents the assessment of the scale (mental disability, etc.)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child, Only

Intervention

Device:
• using a soundproof nebulizer with a music and a funny mask added
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer
• using a silent nebulizer with no extra attachments
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer
• using a routinely employed nebulizer
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer

Locations

Country	Name	City	State
Turkey	Osmangazi University	Eskisehir	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Eda SORKUN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Wong-Baker Faces Pain Scale	was developed by Donna Wong and Connie Morain Baker (1981) to be used to assess children's pain levels. It was revised in 1983 for assessing pain in children over the age of three (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In this scale, the pain score is determined according to the numerical values given to the various faces (Wong & Baker, 1988; Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In our study, the researcher filled in the Wong-Baker Faces Pain Scale before the procedure in order to identify the children who were experiencing pain so that they could be excluded from the study. Only children with a pain score of "0" were taken into the study.	pre-processing
Primary	The Children's Emotional Indicators Scale (CIAS)	This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.	order of operation
Primary	The Child Fear Scale (CFS)	was adapted by McMurty et al. (2011) from the Faces Anxiety Scale to measure anxiety in children undergoing painful medical procedures. The Child Fear Scale displays five faces with a range of expressions, from a neutral expression (0 = no anxiety) to a fearful face (4 = serious anxiety) (McMurtry et al., 2011). Permission is not required for the clinical and research usage of CFS. This scale was used in the study to determine the anxiety level of children before and during the procedure	order of operation